ISO 10012 and ISO 17025 - Doing research about metrology systems confirmation

[filpinto]

Hello!

I'am a student and, i'am doing a research about systems of metrology confirmation, and i have study the norm iso 10012, the 17025, and the 9000, and i wnat to know if someone, can help me in this theme, like the relathionship betwen them and also about G&R, and the system msa.

My email is filcar@portugalmail.pt

Thank you

[Wesley Richardson]

One good place to start is by reading the ISO Abstract for the various documents.

ISO 10012:2003
http://www.iso.org/iso/en/CatalogueD...CSNUMBER=26033

ISO/IEC 17025:2005
http://www.iso.org/iso/en/CatalogueD...S2=120&ICS3=20

ISO 9001:2000
http://www.iso.org/iso/en/CatalogueD...S2=120&ICS3=10

ISO 9001 applies to many types of organizations and is a requirement for quality systems. Organizations can be audited to those requirements, and if they meet them, then Certified and Registered as meeting the requirements.

ISO/IEC 17025 applies to testing and calibration laboratories. This is for both commercial laboratories (the perform work for other companies) and captive laboratories (as part of an organization). Companies can be audited to those requirements, and if they meet them, then Accredited as meeting the requirements.

ISO 10012 is similar to ISO/IEC 17025, but I am not aware of any companies being Accredited to meeting the requirements. If you wish to implement a good measurement and calibration system, but do not require Accreditation, then consider this as an alternative. However, it has nearly been replaced by ISO/IEC 17025.

Gage R&R and MSA refer to requirements related to the automotive industry. The Automotive Industry Action Group (AIAG) http://www.aiag.org issues the ISO/TS 16949:2002. It requires calibration and testing laboratories providing services to ISO/TS 16949 compliant companies to meet the ISO/IEC 17025 requirements. ISO/TS 16949 also requires the complaint companies to comply with measurement system analysis to show capability. As part of that requirement, Gage Repeatability and Reproducibility, along with other analysis, may be required to show this capability.

Wes R.

[filpinto]

Originally Posted by Wesley Richardson

One good place to start is by reading the ISO Abstract for the various documents.

ISO 10012:2003
http://www.iso.org/iso/en/CatalogueD...CSNUMBER=26033

ISO/IEC 17025:2005
http://www.iso.org/iso/en/CatalogueD...S2=120&ICS3=20

ISO 9001:2000
http://www.iso.org/iso/en/CatalogueD...S2=120&ICS3=10

ISO 9001 applies to many types of organizations and is a requirement for quality systems. Organizations can be audited to those requirements, and if they meet them, then Certified and Registered as meeting the requirements.

ISO/IEC 17025 applies to testing and calibration laboratories. This is for both commercial laboratories (the perform work for other companies) and captive laboratories (as part of an organization). Companies can be audited to those requirements, and if they meet them, then Accredited as meeting the requirements.

ISO 10012 is similar to ISO/IEC 17025, but I am not aware of any companies being Accredited to meeting the requirements. If you wish to implement a good measurement and calibration system, but do not require Accreditation, then consider this as an alternative. However, it has nearly been replaced by ISO/IEC 17025.

Gage R&R and MSA refer to requirements related to the automotive industry. The Automotive Industry Action Group (AIAG) http://www.aiag.org issues the ISO/TS 16949:2002. It requires calibration and testing laboratories providing services to ISO/TS 16949 compliant companies to meet the ISO/IEC 17025 requirements. ISO/TS 16949 also requires the complaint companies to comply with measurement system analysis to show capability. As part of that requirement, Gage Repeatability and Reproducibility, along with other analysis, may be required to show this capability.

Wes R.

Thanks for your help, now i'am more sure about the themes.
Be well.
Filipe Pinto

[Graeme]

Originally Posted by Wesley Richardson

ISO 10012 is similar to ISO/IEC 17025, but I am not aware of any companies being Accredited to meeting the requirements. If you wish to implement a good measurement and calibration system, but do not require Accreditation, then consider this as an alternative. However, it has nearly been replaced by ISO/IEC 17025.

Wes,

I respectfully beg to differ on this point. ISO 10012:2003 is not a stand-alone standard. It is a supplement to ISO 9001:2000 that provides requirements and guidance for an organization's measurement management system. It cannot be audited separately -- only as part of ISO 9001. It also has no relationship at all to ISO/IEC 17025, except to the extent that an accredited organization may choose to use 10012 as a framework for the measurement management part of their quality management system.

I have put a file with more information in this thread.

Graeme

[SpaceMan]

Originally Posted by Graeme

Wes,

I respectfully beg to differ on this point. ISO 10012:2003 is not a stand-alone standard. It is a supplement to ISO 9001:2000 that provides requirements and guidance for an organization's measurement management system. It cannot be audited separately -- only as part of ISO 9001. It also has no relationship at all to ISO/IEC 17025, except to the extent that an accredited organization may choose to use 10012 as a framework for the measurement management part of their quality management system.

I have put a file with more information in this thread.

Graeme

A question regarding Requirements of ISO10012. How can 10012 provide requirements for ISO9K2K if it is only recommended for guidance. This has been a sticky point at my company. While I believe that the intent is that the requirements of 10012 are necessary, I continue to lose the debate as I am always reminded that it is only referenced as "guidance" not not as "SHALL". The point of contention is in measurement uncertainty and whether or not we are required to calculate it.

[pilchard]

Abstract

ISO 10012:2003 specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and demonstrate compliance with metrological requirements. It specifies quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.

ISO 10012:2003 is not intended to be used as a requisite for demonstrating conformance with ISO 9001, ISO 14001 or any other standard. Interested parties can agree to use ISO 10012:2003 as an input for satisfying measurement management system requirements in certification activities. Other standards and guides exist for particular elements affecting measurement results, for example, details of measurement methods, competence of personnel, interlaboratory comparisons.

ISO 10012:2003 is not intended as a substitute for, or as an addition to, the requirements of ISO/IEC 17025.

[Miner]

To find out more about GRR, try searching the Measurement Systems Analysis (MSA) forum:

http://elsmar.com/Forums/forumdispla...c&daysprune=-1

[Graeme]

Originally Posted by SpaceMan

A question regarding Requirements of ISO10012. How can 10012 provide requirements for ISO9K2K if it is only recommended for guidance. This has been a sticky point at my company. While I believe that the intent is that the requirements of 10012 are necessary, I continue to lose the debate as I am always reminded that it is only referenced as "guidance" not not as "SHALL". The point of contention is in measurement uncertainty and whether or not we are required to calculate it.

I am in the process of discussing this with someone on the committee that wrote it ... hopefully I will have some clarification in a few days.

Graeme